Office hysteroscopic sterilization using the Essure micro-insert device
M. Martinho, J. Bernardes
Unit of Endoscopy, Department of Gynaecology and Obstetrics, Hospital S.
João, Faculty of Medicine, University of Porto, Portugal
Objective: The Essure permanent birth control (pbc) device is a
minimally invasive transcervically placed micro-insert that occludes the
Fallopian tubes, resulting in permanent female sterilization. This device is, as
far as we know, the first medical device to obtain the FDA approval, for
hysteroscopic sterilization. The author’s report their experience using this
device in an office setting and present data about the safety, effectiveness and
tolerance of the procedure.
Methods: The method was presented to women seeking permanent birth
control that met the patient selection criteria recommended. Associated
pathologies increasing operative risk were a taken in consideration and favoured
the choice of this method. After an exhaustive explanation of the procedure,
women gave their written informed consent and the procedure was scheduled.
Essure pbc micro-inserts were inserted in the proximal portion of the Fallopian
tubes under hysteroscopic visualisation with paracervical block or no local
anaesthesia, in an office setting. The procedure was performed preferentially in
the follicular phase of the cycle and women were advised to use an effective
contraception method. The patients were evaluated 1 month after the procedure
and a hysterosalpingogram scheduled at 3 months. We analysed retrospectively all
clinical files and evaluated, the safety of the procedure, the tolerance and
recovery from the procedure, tubal occlusion and device placement.
Results: From May 2002 to January 2004, 37 women aged 26- 47 (38,75)
were submitted to the procedure; 20 (54,05%) had associated pathology increasing
the operative risk. Bilateral device placement was achieved in 33 (89,19%) women.
In 2 (5,40%) women a second procedure was required to accomplish bilateral
placement. In 1 (2,70%) only unilateral placement was possible. In 1 case
(2,70%) expulsion of one device occurred. 32 (86,49%) women found the procedure
to be highly acceptable. 31 (83,78%) women received diazepam, 5mg, orally prior
placement and N butil bromide of hioscine i.v. during procedure; 14 (37,84 %)
patients had paracervical block and 21 (56,76%) needed analgesic medication
during or immediately after the procedure but no patient complaint from
post-procedure pain at the moment of discharge. No major complications occurred.
All patients but two had a correct device location and bilateral tubal occlusion
3 month after procedure as confirmed by HSG. These two women achieved it at 6th
months post-procedure. 26 women were able to rely on Essure for permanent birth
control and no pregnancies occurred until now.
Conclusion: According to our experience this method can be performed
safely and with minimal patient’s discomfort in an office setting. It was
associated with a rapid recovery, high patient satisfaction and low rate of
complications. Data presented are similar to those in the literature and suggest
that this procedure may be an effective alternative to women seeking
sterilization without requirement of incisions and general anaesthesia and
especially to women with increased operative risk.